Inflatable ventricular partitioning device

ABSTRACT

This invention is directed to a device and method of using the device for partitioning a patient&#39;s heart chamber into a productive portion and a non-productive portion. The device is particularly suitable for treating patients with congestive heart failure. The device has an inflatable partitioning element which separates the productive and non-productive portions of the heart chamber and in some embodiments also has a supporting element, which may also be inflatable, extending between the inflatable partitioning element and the wall of the non-productive portion of the patient&#39;s heart chamber. The supporting element may have a non-traumatic distal end to engage the ventricular wall or a tissue penetrating anchoring element to secure the device to the patient&#39;s heart wall.

FIELD OF THE INVENTION

The present invention relates generally to the field of treatingcongestive heart failure and more specifically, to a device and methodfor partitioning a patient's heart chamber and a system for deliveringthe treatment device.

BACKGROUND OF THE INVENTION

Congestive heart failure (CHF) is characterized by a progressiveenlargement of the heart, particularly the left ventricle and is a majorcause of death and disability in the United States. Approximately500,000 cases occur annually in the U.S. alone. As the patient's heartenlarges, it cannot efficiently pump blood forward with each heart beat.In time, the heart becomes so enlarged the heart cannot adequatelysupply blood to the body. Even in healthy hearts only a certainpercentage of the blood in a patient's left ventricle is pumped out orejected from the chamber during each stroke of the heart. The pumpedpercentage, commonly referred to as the “ejection fraction”, istypically about sixty percent for a healthy heart. A patient withcongestive heart failure can have an ejection fraction of less than 40%and sometimes lower. As a result of the low ejection fraction, a patientwith congestive heart failure is fatigued, unable to perform even simpletasks requiring exertion and experiences pain and discomfort. Further,as the heart enlarges, the internal heart valves such as the mitralvalve, cannot adequately close. An incompetent mitral valve allowsregurgitation of blood from the left ventricle back into the leftatrium, further reducing the heart's ability to pump blood forewardly.

Congestive heart failure can result from a variety of conditions,including viral infections, incompetent heart valves (e.g. mitralvalve), ischemic conditions in the heart wall or a combination of theseconditions. Prolonged ischemia and occlusion of coronary arteries canresult in myocardial tissue in the ventricular wall dying and becomingscar tissue. Once the myocardial tissue dies, it is less contractile(sometimes non-contractile) and no longer contributes to the pumpingaction of the heart. It is referred to as hypokinetic. As the diseaseprogresses, a local area of compromised myocardium may bulge out duringthe heart contractions, further decreasing the heart's ability to pumpblood and further reducing the ejection fraction. In this instance, theheart wall is referred to as dyskinetic or akinetic. The dyskineticregion of the heart wall may stretch and eventually form an aneurysmicbulge.

Patients suffering from congestive heart failure are commonly groupedinto four classes, Classes I, II, III and IV. In the early stages,Classes I and II, drug therapy is presently the most commonly prescribedtreatment. Drug therapy typically treats the symptoms of the disease andmay slow the progression of the disease, but it can not cure thedisease. Presently, the only permanent treatment for congestive heartdisease is heart transplantation, but heart transplant procedures arevery risky, extremely invasive and expensive and are performed on asmall percentage of patients. Many patient's do not qualify for hearttransplant for failure to meet any one of a number of qualifyingcriteria, and, Furthermore, there are not enough hearts available fortransplant to meet the needs of CHF patients who do qualify.

Substantial effort has been made to find alternative treatments forcongestive heart disease. For example, surgical procedures have beendeveloped to dissect and remove weakened portions of the ventricularwall in order to reduce heart volume. This procedure is highly invasive,risky and expensive and is commonly only done in conjunction with otherprocedures (such as heart valve replacement or coronary artery by-passgraft). Additionally, the surgical treatment is usually limited to ClassIV patients and, accordingly, is not an option for patients facingineffective drug treatment prior to Class IV. Finally, if the procedurefails, emergency heart transplant is the only presently availableoption.

Other efforts to treat CHF include the use of an elastic support, suchas an artificial elastic sock placed around the heart to prevent furtherdeleterious remodeling.

Additionally, mechanical assist devices have been developed asintermediate procedures for treating congestive heart disease. Suchdevices include left ventricular assist devices and total artificialhearts. A left ventricular assist device includes a mechanical pump forincreasing blood flow from the left ventricle into the aorta. Totalartificial heart devices, such as the Jarvik heart, are usually usedonly as temporary measures while a patient awaits a donor heart fortransplant.

Recently, improvements have been made in treating patient's with CHF byimplanting pacing leads in both sides of the heart in order tocoordinate the contraction of both ventricles of the heart. Thistechnique has been shown to improve hemodynamic performance and canresult in increased ejection fraction from the right ventricle to thepatient's lungs and the ejection fraction from the left ventricle to thepatient's aorta. While this procedure has been found to be successful inproviding some relief from CHF symptoms and slowed the progression ofthe disease, it has not been able to stop the disease.

SUMMARY OF INVENTION

The present invention is directed to a ventricular partitioning deviceand method of employing the device in the treatment of a patient withcongestive heart failure. Specifically, the ventricular chamber of theCHF patient is partitioned by the device so as to reduce its totalvolume and to reduce the stress applied to the heart and, as a result,improve the ejection fraction thereof.

A ventricular partitioning device embodying features of the inventionhas an inflatable partitioning element, which is configured to partitionthe patient's ventricular heart chamber into a main productive portionand a secondary non-productive portion. The inflatable partitioningelement may be at least in part disc shaped and hollow. The partitioningdevice preferably has a supporting or spacing element extending from thedistal side of the inflatable partitioning element for non-traumaticallyengaging a region of the patient's ventricular wall defining in part thesecondary non-productive portion to space a central portion of thepartitioning element from the heart wall. The supporting or spacingelement may itself be inflatable and preferably has an interior in fluidcommunication with the interior of the partitioning element.

The supporting element of the device has a length configured to extendto the heart wall, supporting and spacing the partitioning element fromthe heart wall. The supporting element may have an inner lumen extendingtherein for delivery of therapeutic or diagnostic agents through theports provided along the length thereof.

The partitioning device may be delivered percutaneously orintraoperatively. It is relatively easy to install and providessubstantial improvement in the ejection fraction of the patient's heartchamber. A suitable delivery system is described in co pendingapplication Ser. No. 10/212,032, filed on Aug. 1, 2002 which isincorporated herein in it's entirety. These and other advantages of theinvention will become more apparent from the following detaileddescription of the invention and the accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a ventricular partitioning device in aninflated state embodying features of the invention.

FIG. 1B is a perspective view of a ventricular portioning device in adeflated state embodying features of the invention.

FIG. 1C is an enlarged view of the encircled region of FIG. 1B

FIG. 2 is a schematic view of a patient's left ventricular chamberillustrating the partitioning device shown in FIG. 1A disposed withinthe chamber separating a working portion of the chamber from anon-working portion of the chamber.

FIG. 3 is a perspective view of an alternative design of thepartitioning device without a supporting member.

FIG. 4 is a schematic view of a patient's left ventricular chamberillustrating the partitioning device being deployed on a deliverysystem.

FIG. 5 is a schematic view of the patient's left ventricular chamberillustrating the partitioning device Shown in FIG. 3 disposed within thechamber separating a working portion of the chamber from a non-workingportion of the chamber.

FIG. 6 is an elevational view of a delivery system for the partitioningdevice shown in FIG. 3 with the inflatable partitioning element in adeflated condition.

FIG. 7 is an elevational view of a delivery system as shown in FIG. 6with the partitioning element in an inflated condition.

FIG. 8 is a perspective view of an alternative partitioning device whichhas an elongated, distally extending stem with non-traumatic bumperelements on the distal extremity.

DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION

FIGS. 1A and 1B illustrate a partitioning device 10 which embodiesfeatures of the invention and which includes an inflatable partitioningelement 12 and an inflatable supporting element 14. The partitioningelement 12 may contain anchoring members 16 around its edge 18 to engagethe heart wall 20 upon expansion. The partitioning device 10 isdelivered in a deflated form through a catheter. The inflatablepartitioning element may be disc shaped and hollow. When inflated thesupporting element 14 extends distally from the center of thepartitioning element 12 and has a distal end 22 which provides ayielding engagement with a heart wall 20 when deployed within apatient's heart chamber 24.

The partitioning element 12 has a peripheral edge 18. The edge 18 maycontain anchoring members 16 which are configured to hold thepartitioning device 10 in a deployed position within the patient's heartchamber 24. Preferably, the anchoring elements 16 penetrate into tissueof the patient's heart wall 20 in order to secure the partitioningelement 12 so as to partition the ventricular chamber 24 in a desiredmanner. The partitioning element 12 may contain a hub 26 having a oneway valve for inflation of both the partitioning element 12 and thesupporting element 14.

FIG. 2 illustrates the placement of partitioning device 10 within apatient's left ventricle 24. The partitioning element 12 partitions thepatient's heart chamber 24 into a main productive portion 27 and asecondary, essentially non-productive portion 28. The productive portion27 is smaller than the original ventricular chamber 24 and provides foran improved ejection fraction. The partitioning increases the ejectionfraction and provides an improvement in blood flow through the heartchamber. Over time, the non-productive portion 28 fills initially withthrombus and subsequently cellular growth. Bio-resorbable fillers suchas polylactic acid, polyglycolic acid, polycaprolactone and copolymersand blends may be employed to fill the non-productive portion 28.Fillers may be suitably supplied in a suitable solvent such as DMSO.Other materials which accelerate tissue growth may be deployed in thenon-productive portion 28. In some embodiments the supporting element 14may fill a portion or all of the non-productive chamber 28.

An alternative partitioning device 30 is shown in FIG. 3 wherein theinflatable partitioning element 32 is held in place by anchoring members34 disposed about the periphery 36. In this embodiment the partitioningelement 32 does not have a distal supporting element extending from it'sdistal face 38. The proximal face 40 has a hub 42 which has a inflationport for injection inflation fluid into the interior of the element 32.

A suitable delivery system for the partitioning devices described aboveis described in co-pending application Ser. No. 10/212,032 filed on Aug.1, 2002 which is incorporated herein in its entirety. FIGS. 4, 6 and 7illustrate a suitable delivery system 44 with a partitioning device 30as shown in FIG. 3. The delivery system 44 includes a control handle 46with a delivery catheter 48 and a detachment mechanism including coil 50secured to the distal end of the delivery catheter for releasing thepartitioning device 30 from the delivery system 44 The delivery catheter48 may be provided with an inner lumen (not shown) through whichtherapeutic or diagnostic fluids may be delivered. The delivery catheter48 extends through the handle 50 and the proximal end of the catheter 48is connected to a balloon inflation port 52.

As shown in FIG. 4, the delivery system 44 may be introduced into apatient's body through a percutaneously introduced guide catheter orcannula 54 which has an inner lumen (not shown). The partitioning device30 is slidably disposed within the inner lumen of guide catheter 54. Thedelivery system 44 is advanced distally within the inner lumen of theguide catheter 54 and engages the ventricular wall 56. With the deliverysystem 44 held in place, the partitioning element 32 is inflated and theanchoring members 34 penetrate into tissue of the patient's heart wall56, as shown in FIG. 5, to secure the partitioning device 30 within thepatient's heart chamber 58 to partition the chamber into productiveportion 60 and non-productive portion 62. The delivery system 44 and theguide catheter 54 may then be removed from the patient. The proximal endof the guide catheter 54 is provided with an injection port 64 to injecttherapeutic or diagnostic fluids through the inner lumen thereof intothe patient's heart chamber 58.

FIG. 8 illustrates another alternative inflatable partitioning device 70which has a partitioning element 72 and a stem 74 which extends distallyfrom the distal face 76 of the partitioning element. The distalextremity of the stem 74 has three J-shaped bumpers 78 which allow fornon-traumatic engagement with the wall of the patient's non-productiveportion of the heart chamber. A variety of other non-traumatic bumpersmay be employed, such as those described in co-pending application Ser.No. ______, which was filed on Jan. 9, 2004 and which was entitled“VENTRICULAR PARTITIONING DEVICE”. This application has been assigned tothe present assignee and is incorporated herein in its entirety. Theperiphery of partitioning element 72 is provided with a plurality ofanchoring elements 80 for securing the device to the ventricular wall. Ahub 82 is provided on the proximal face 84 of the partitioning element72 for delivery and inflation of the partitioning element as previouslydescribed.

To assist in properly locating the partitioning device duringadvancement and placement thereof into a patient's heart chamber, it maybe provided with markers at desirable locations that provide enhancedvisualization by eye, by ultrasound, by X-ray, or other imaging orvisualization means. Radiopaque markers may be made with, for example,stainless steel, platinum, gold, iridium, tantalum, tungsten, silver,rhodium, nickel, bismuth, other radiopaque metals, alloys and oxides ofthese metals.

The partitioning device 10, 30 and 70 may be formed of suitablebiocompatitble polymeric material which include expandedpolytetrfluoroethylene (ePTFE), polyethylene terephthalate (PET),polyesters such as Hytrel®, polyamides such as Nylon and polyurethane.The compliance may range from about 50 to about 1000%. The inflatablepartitioning element of the device in the expanded configuration hasradial dimensions from about 5 to about 60 mm, preferably about 20 toabout 50 mm, as measured from the center line axis. The aspect ratio ofthe thickness of the inflatable partitioning element at its thickestportion to the diameter of the inflatable partitioning element is fromabout 1:10 to about 1:1, preferably about 1:10 to about 1:2.

The delivery catheter and the guide catheter may be formed of suitablehigh strength polymeric material such as PEEK (polyetheretherketone),polycarbonate, PET, Nylon, and the like. To the extent not otherwisedescribed herein, the various components of the partitioning device anddelivery system may be formed of conventional materials and in aconventional manner as will be appreciated by those skilled in the art.

The inflatable partitioning and support elements may be inflated with avariety of fluids, preferably liquids such as saline or contrast fluids.Liquids which become more viscous or harden in situ may also be used. Ifthe inflatable elements are formed of bioabsorable materials, theinflation fluid should be readily absorbed within the patient'sbloodstream and should not have significant detrimental affects.

While particular forms of the invention have been illustrated anddescribed herein, it will be apparent that various modifications andimprovements can be made to the invention. For example an inflatablepartitioning element may be used to occlude an atrial appendage of theheart. Moreover, individual features of embodiments of the invention maybe shown in some drawings and not in others, but those skilled in theart will recognize that individual features of one embodiment of theinvention can be combined with any or all the features of anotherembodiment. Accordingly, it is not intended that the invention belimited to the specific embodiments illustrated. It is intended thatthis invention to be defined by the scope of the appended claims asbroadly as the prior art will permit.

Terms such a “element”, “member”, “device”, “section”, “portion”,“steps”, “means” and words of similar import when used herein shall notbe construed as invoking the provisions of 35 U.S.C. §112(6) unless thefollowing claims expressly use the terms “means” followed by aparticular function without specific structure or “step” followed by aparticular function without specific action. All patents and patentapplications referred to above are hereby incorporated by reference intheir entirety. Accordingly, it is not intended that the invention belimited, except as by the appended claims.

1. A device for treating a patient's heart to improve cardiac function,comprising: a. an inflatable partitioning element which has an outerperiphery configured to engage inner surfaces of a ventricular chamberof the patient's heart to partition the chamber into a main productiveportion and a secondary, non-productive portion; and b. at least oneanchoring element configured to secure the inflatable partitioningelement within the ventricular chamber.
 2. The device of claim 1 whereinthe inflatable partitioning element has a proximal face which defines inpart the main productive portion of the ventricular chamber.
 3. Thedevice of claim 1 wherein the inflatable partitioning element has adistal face which defines in part the secondary non-productive portionof the ventricular chamber.
 4. The device of claim 1 wherein a pluralityof anchoring elements are provided on the periphery of the inflatablepartitioning element.
 5. The device of claim 1 wherein at least oneanchoring element is connected to the proximal face of the inflatableelement.
 6. The device of claim 1 wherein the inflatable partitioningelement has a distally extending supporting element configured to engagea region of the non-productive portion of the ventricular chamber. 7.The device of claim 6 wherein the distally extending supporting elementis inflatable.
 8. The device of claim 6 wherein the distally extendingsupporting element has a distal end and an anchoring element on thedistal end.
 9. The device of claim 8 wherein the anchoring element onthe distal end of the supporting element is configured to engage aregion of the non-productive portion of the ventricular chamber.
 10. Thedevice of claim 6 wherein the supporting element has a distal extremitywhich is configured to non-traumatically engage a region of thepatient's ventricular wall defining in part the secondary non-productiveportion of the heart chamber.
 11. The device of claim 6 wherein thesupporting element fills a substantial portion of the non-productiveportion of the ventricular chamber.
 12. The device of claim 1 whereinthe supporting element fills the entire non-productive portion of thepatient's heart chamber.
 13. The device of claim 1 wherein theinflatable partitioning element is at least in part disk shaped.
 14. Thedevice of claim 1 wherein the inflatable partitioning element is hollow.15. The device of claim 1 wherein a connecting hub is provided on aproximal portion of the partitioning element.
 16. The device of claim 15wherein the hub contains a one-way valve to facilitate inflation of thepartitioning element.
 17. The device of claim 1 wherein the partitioningelement is formed of biocompatible polymeric material
 18. The device ofclaim 17 wherein the biocompatible polymeric material is selected from agroup consisting of expanded polytetrafluoroethylene, nylon,polyethylene terephthalate, polyester and polyurethane.
 19. The deviceof claim 1 wherein the inflatable partitioning element has an aspectratio of thickness to diameter of about 1:10 to about 1:2.
 20. Thedevice of claim 1 wherein the at least one anchoring element is a hookor a barb.
 21. A device for increasing the ejection fraction of apatient's heart chamber, comprising: a. an inflatable partitioningelement which has an interior configured to receive inflation fluid,which has a peripheral edge and which is configured to partition aventricular chamber of the patient's heart into a main productiveportion and a secondary, non-productive portion; and b. a distallyextending supporting element configured to engage a region of thenon-productive portion of the ventricular chamber.
 22. The device ofclaim 21 wherein the distally extending supporting element isinflatable.
 23. The device of claim 22 wherein the inflatable distalextending supporting element has an interior in fluid communication withthe interior of the partitioning element.
 24. The device of claim 21wherein partitioning element has a hub on a proximal face thereof. 25.The device of claim 24 wherein the hub has a one way valve configured todeliver inflation fluid to the interior of the partitioning element. 26.The device of claim 21 wherein the distally extending supporting elementis configured to non-traumatically engage a region of the non-productiveportion of the ventricular chamber.
 27. The device of claim 21 whereinthe distally extending supporting element is a stem.
 28. The device ofclaim 27 wherein the stem has at least one J-shaped distal extremity.29. The device of claim 27 wherein the stem has a plurality of J-shapeddistal extremities.
 30. The device of claim 27 wherein the stem has adistal extremity with an anchoring element configured to secure the stemto a region of the non-productive portion of the ventricular chamber.31. The device of claim 30 wherein the anchoring element is a coil witha tissue penetrating tip.
 32. The device of claim 21 wherein theinflatable partitioning element is at least in part disk shaped.
 33. Adevice for treating a patient's heart to improve the cardiac functionthereof, comprising: a. an inflatable partitioning means which has anouter periphery configured to engage inner surfaces of a ventricularchamber of the patient's heart to partition the chamber into a mainproductive portion and a secondary, non-productive portion; and b. atleast one anchoring means configured to secure the inflatablepartitioning means within the ventricular chamber.
 34. The device ofclaim 33 wherein the inflatable partitioning means is disc shaped. 35.The device of claim 33 wherein the inflatable partitioning means ishollow
 36. The device of claim 33 wherein the anchoring means areprovided on the outer periphery of the inflatable partitioning means.37. The device of claim 36 wherein the anchoring means are hooks orbarbs.
 38. The device of claim 33 including distally extending supportmeans configured to engage a region of the non-productive portion of theventricular chamber.
 39. The device of claim 38 wherein the distallyextending support means is configured to non-traumatically engage aregion of the patient's ventricular wall defining in part the secondarynon-productive portion of the ventricular chamber.
 40. The device ofclaim 38 wherein the distally extending support means is inflatable. 41.The device of claim 38 wherein the distally extending support means is astem.
 42. The device of claim 38 wherein the distally extending supportmeans has a distal end and an anchoring means on the distal end.
 43. Thedevice of claim 42 wherein the anchoring means on the distal end of thesupporting element is configured to engage a region of thenon-productive portion of the ventricular chamber.
 44. The device ofclaim 43 wherein the anchoring means is a coil with a tissue penetratingtip.
 45. The device of claim 38 wherein the support means has a distalextremity which is configured to non-traumatically engage a region ofthe patient's ventricular wall defining in part the secondarynon-productive portion of the heart chamber.
 46. The device of claim 38wherein the support means fills a substantial portion of thenon-productive portion of the ventricular chamber.
 47. A method oftreating a patient with congestive heart failure, comprising: a.providing a treatment device having an inflatable partitioning elementwith a peripheral edge and at least one anchoring element; b.positioning the treatment device within a ventricular chamber of thepatient's heart with the peripheral edge of the partitioning elementengaging a wall of the ventricular chamber to partition the chamber intoproductive and non-productive portions; and c. spacing a distal face ofthe inflatable partitioning element from a region of a ventricular walldefining at least in part the non-productive ventricular chamber. 48.The method of claim 47 wherein the partitioning device includes andistal extending support element which spaces the partitioning.
 49. Themethod of claim 47 wherein the partitioning device is delivered in adeflated configuration and expanded in position within the patient'sheart wall.
 50. The method of claim 47 wherein the partitioning deviceis first positioned within an inner lumen of an elongated catheter andthe catheter is percutaneously introduced into the patient's vasculatureand advanced therein to the patient's heart chamber wherein thereinforced membrane is discharged from the catheter.
 51. The method ofclaim 47 wherein the edge of the partitioning device is secured to theheart wall defining at least in part the heart chamber by the at leastone anchoring member provided on the edge of the partitioning device.52. The method of claim 47 wherein the partitioning device is positionedwithin a patient's heart chamber to occlude an atrial appendage.
 53. Adevice for increasing the ejection fraction of a patient's heartchamber, comprising: a. an inflatable partitioning means which has aninterior configured to receive inflation fluid, which has a peripheraledge and which is configured to partition a ventricular chamber of thepatient's heart into a main productive portion and a secondary,non-productive portion; and b. a distally extending supporting meansconfigured to engage a region of the non-productive portion of theventricular chamber.
 54. The device of claim 53 wherein the distallyextending supporting means is configured to non-traumatically engage aregion of the non-productive portion of the ventricular chamber.
 55. Thedevice of claim 54 wherein the distally extending support means is astem.
 56. The device of claim 55 wherein the stem has at least oneJ-shaped distal extremity.
 57. The device of claim 55 wherein the stemhas a plurality of J-shaped distal extremities.
 58. The device of claim53 wherein the supporting means has a distal extremity with an anchoringmeans configured to secure the support means to a region of thenon-productive portion of the ventricular chamber.
 59. The device ofclaim 58 wherein the anchoring means is a coil with a tissue penetratingtip.
 60. The device of claim 53 wherein the inflatable partitioningmeans has a hub with a one-way valve to facilitate introducing inflationfluid to the interior of the inflatable partitioning means.
 61. Thedevice of claim 53 wherein the inflatable partitioning means has anaspect ratio of the thickness of the inflatable partitioning means tothe diameter thereof is about 1:10 to about 1:2.
 62. A method oftreating a patient with congestive heart failure, comprising the stepsof: a. providing a treatment device having an inflatable partitioningelement with a peripheral edge and at least one anchoring element; b.positioning the treatment device within a ventricular chamber of thepatient's heart with the peripheral edge of the partitioning elementengaging a wall of the ventricular chamber to partition the chamber intoproductive and non-productive portions; and c. spacing a distal face ofthe inflatable partitioning element from a region of a ventricular walldefining at least in part the non-productive ventricular chamber. 63.The method of claim 62 including the step of providing an inflatablesupporting element extending distally from the inflatable partitioningelement.
 64. The method of claim 62 including the steps of deliveringthe partitioning device in a deflated configuration and inflating thedevice in position within the patient's heart wall.
 65. The method ofclaim 53 including the step of first positioning the partitioning devicewithin an inner lumen of an elongated catheter and percutaneouslyintroducing the catheter into the patient's vasculature and the step ofdischarging the device within the patient's heart chamber.
 66. Themethod of claim 65 including the step of securing an outer periphery ofthe inflatable partitioning device within the patient's heart chamber bythe at least one anchoring member provided on the periphery of thepartitioning device.
 67. A device for treating a patient's heart toimprove cardiac function thereof, comprising: a. an inflatablepartitioning element which has a peripheral edge and which is configuredto partition a ventricular chamber of the patient's heart into a mainproductive portion and a secondary, non-productive portion; and b. asupporting element which extends distally from the inflatablepartitioning element and which is configured to engage a region of thenon-productive portion of the ventricular chamber. c. at least oneanchoring element configured to secure the inflatable partitioningelement within the ventricular chamber.
 68. The device of claim 67wherein an anchoring element is provided on a distal extremity of thedistally extending support element.
 69. The device of claim 68 whereinthe anchoring element is a helical coil with a tissue penetrating distaltip.